QUALITY CONTROL

A Model Program for the Food Industry

Ingredient Specifications . . . . . . . . . . . . . . . . . 3 standards of identity are definitions for a specific food

product to avoid confusion or mislabeling of similar
Approved Supplier List . . . . . . . . . . . . . . . . . . 5 processed foods. Milk is a good example. The standard
for skim milk is less than 1/2 percent fat, while the
standard for whole milk is at least 3-1/4 percent fat.
Product Formulation/Recipe . . . . . . . . . . . . . 6
Quality defined by regulations, policies or standards is
controlled by federal and state agencies. Failure to meet
Product Standards . . . . . . . . . . . . . . . . . . . . . . 6 the degree of excellence defined by the regulations,
policies or standards of identity is illegal.
Manufacturing Procedures . . . . . . . . . . . . . . . 8 The government-controlled attributes of food are
another important measure of food quality. Therefore,
In-Process Records . . . . . . . . . . . . . . . . . . . . . 8 the first category of food quality is critical attributes
and includes factors that affect safety, wholesomeness or
Packaging and Labeling . . . . . . . . . . . . . . . . . 9 legality.
Besides the critical attribute of safety, other
properties of the food product should be used to define
Good Manufacturing Practices & Sanitation 10 overall quality. These other attributes are defined by
industry, the processor or consumer demand. An
Warehousing . . . . . . . . . . . . . . . . . . . . . . . . . . 10 example of this is the particle size of flour, the shape of
a frankfurter or sausage or the color and flavor of salad
Laboratory Analysis . . . . . . . . . . . . . . . . . . . 11 dressing.
Two other categories that classify or describe
Recall Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 additional quality characteristics of food products are
called major and minor attributes. A major attribute is
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 determined to be necessary for the food but not essential
from a safety and legal standpoint. A major attribute
could be fat content of hamburger meat or the portion
The dictionary defines quality as an important
weight of green peas in a frozen prepared dinner. A
character, a degree of excellence or a necessary attribute.
minor attribute is wanted but not absolutely essential to
A group of activities designed to assure a standard of
the product or not easily determined. For instance, the
excellence is called Quality Control.
desirable flavor properties of foods are highly subjective
Food is basic for life. Quality or excellence in our
(dependent upon people), not easily measured and
food supply should be an important concern to all food
should be a minor attribute. However, flavor defects that
processors. Safety and wholesomeness are the most
can reduce sales should be classified in the major
important attributes of food quality. The lack of quality
category.
as it relates to safety and wholesomeness can result in
The critical, major and minor attributes usually
personal injury, sick-ness or death. Food-borne illness is
describe the key chemical, physical, and microbiological
an example of sickness or even death when unsafe foods
properties of a food. The manufacturing process and
are produced and eaten.
many known or unknown factors will affect the finished
Certain foods or food products are defined by
product. Therefore, a control program is the tool for the
regulations or policies called standards of identity. These
food processor to use to assure that quality targets are

Commitment + Awareness + Teamwork + Communication + Quality Control

= Safe, Wholesome and Consistent Food Products
Figure 1. Quality is everyone’s business. The organizational structure, a reporting system and open communication
are necessary for success.

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met. G Good Manufacturing Practices (GMP) Requirements
Finally, to develop a quality control program, you G Recall Program
must define expected food quality to provide a system of G Warehousing, Shipping and Receiving Program
quality measurement, allow a means for action not G Laboratory Analysis
reaction, help to minimize costly errors, and reduce the
risk of food safety and wholesomeness defects. What is
needed for a quality control program? The first step is a
Ingredient Specifications
strong commitment from management. Quality control The quality of the finished food product after
must have the same priority as the profit and loss manufacture depends on the quality of the raw materials
statement for the business. and ingredients. The best starting point for developing
Quality doesn't cost, it pays. Beyond commitment, ingredient specifications is the supplier. Ask for a copy
management must instill quality aware-ness throughout of the supplier's ingredient specifications. Review the
the organizational structure. A successful quality information and modify the specifications to your needs.
program needs people. It is important that the food Discuss and settle specifications with the supplier. At
operation personnel function as a team and openly times, specifications need to be negotiated with
communicate to identify problems, issues or suppliers. Custom specifications from suppliers are
opportunities. Once key elements of a quality control possible. The ingredient specifications should be
program are in place (management commitment, quality documented in a form consistent with the processor's
awareness, a team effort and open communication), needs. Ingredient specifications document should
develop and use additional tools. include:
The basic tools of quality control are: G Name of Ingredient
G Ingredient Specifications G Internal Code Number
G Approved Supplier List G Effective Date
G Product Formulas G Basic Description of Ingredient
G Product Standards (Specifications) G Specifications categorized as:
G Manufacturing Procedures G Critical
G Critical Control Point Identification/Sampling G Major
Program G Minor
G In-Process Analysis, Records and Reporting G Action and Reject Levels
Packaging Specifications G Ingredient Statement
G Label Specifications
G Cleaning and Sanitizing Program The prepared ingredient specifications become a tool
for control. The information under each heading should
be simple but informative. Figure 3 is an example of an
ingredient specification. It is simple and informative.
The basic description is short and to the point. Critical
specifications include two items associated with public
safety. Critical specifications can also include factors
influencing wholesomeness or legality. Action levels are
used as a reference point to identify a potential problem.
If the ingredient consistently reaches action levels, notify
your supplier. The reject level is the point of refusing
delivery of the ingredient. The ingredient statement for
the raw material is a reference point to assure that the
supplier has not changed the material. The final key
point for ingredient specifications is for the supplier to
know and agree to the content of the document.

Figure 2. Dry Ingredient Storage Area. Keep

materials, ingredients and supplies off the floor and
in closed containers. Repair torn bags.

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 GROUND BLACK PEPPER
CODE NUMBER: A-001
PRODUCT DESCRIPTION: Ground black pepper shall be prepared from the dried, immature berries of
Piper nigrum. The color can vary from light-gray to a speckled black-gray.
EFFECTIVE DATE: Today's date
CRITICAL SPECIFICATIONS: Action Level Reject Level
Salmonella none Positive in 100
E. Coli none Positive
MAJOR SPECIFICATIONS: Action Level Reject Level
Granulation 4.5% (retained on a U.S. >5%
#35 sieve)

Volatile Oil 2.5% <2%

Moisture 11.5% >12%
Color light-gray to black-gray off-white to light gray
Yeast/Mold <100 per gram >100 per gram
MINOR SPECIFICATIONS: None
INGREDIENT STATEMENT: Ground Black Pepper
Figure 3. An Ingredient Specification Document

The approved supplier list should contain the

Approved Supplier List following information:
For each ingredient, an approved supplier list should G Ingredient Name and Internal Code
exist and be available to individuals responsible for G Supplier Name, Address, Key Contact and Phone
purchasing and quality control. In theory, more than one Number
supplier per ingredient is desirable. A good target is G Trade Name of Ingredient
three suppliers per ingredient. A supplier is an ingredient G Supplier Code Number
manufacturer, a broker or a distributor. When necessary,
identify both the manufacturer and distributor on the
approved supplier list. Product Formulation/Recipe
Approve all sources of supply only after careful Proprietary formulas are important. For each food
evaluation and review of their performance in the product, written documentation of the formula or recipe
product. For approving alternate ingredient sources two should exist and be available for use by selected
key questions are: individuals. The formulas should be used daily as a
G Does the ingredient meet the existing or needed means to assure consistency between batches, lots and
specifications? even days of production. Manufacturing personnel need
G Does the new ingredient provide the same or desired to know the recipe to assure that the product is
finished product? formulated correctly. For highly confidential formulas,
At times, only one acceptable supply source may be the production worker does not need all the details. A
available because of special requirements. In this case, simplified recipe can be provided to assure that the secret
alternate sources should be listed for emergency stays a secret.
purposes. The emergency source of the ingredient should The individual formula sheets can have a variety of
be one that has been tested and best approaches all formats. Key aspects of any formula document are:
specifications. G Name of the product.
G Internal code number.

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 Effective date.
G
G Listing of the ingredients.
Product Standards
G Listing of the ingredient code. A key tool to assure quality in a finished processed
G Percentage formula. food is the product standard document. Product
G Batch formula. standards define the food by physical, chemical and
G Batch yield. microbiological characteristics. Appearance, aroma,
G Ingredient statement. flavor and texture can and should also be considered for
product standards.
Additional information that can be part of a formula Physical characteristics include size, shape,
document are packaging, lot size, regulatory constraints, dimensions, weight, volume, count per package or
net weight, package count per batch, etc. Be flexible with container, presence of fines, or any other special features
the format since the formula may purposefully be which define the particular food. Moisture, fat, protein,
modified and the kind of information needed may change. ash, fiber and carbohydrates are the basic chemical
If nothing else, the batch size may change due to business characteristics. Additional chemical criterion such as
growth or decline. salt, sodium, cholesterol, etc., are used to chemically
Figure 4 is an example of a formula sheet. define food products. Chemical standards are necessary
when using nutritional labeling or making label claims
for low sodium, higher fiber or other nutritional facts.
Microbiological standards will be dependent upon
the specific food item. First consider food poisoning
organisms when developing product standards for a
quality control program. Food safety is the responsibility

CHILI WITHOUT BEANS

CODE NUMBER: B-001
EFFECTIVE DATE: Today's date
Ingredients Code % Formula Batch Formula (lbs.)
Beef, 75% lean A-002 40.00 240.0
Tomato Paste, 32% T. S. A-003 11.74 70.4
Water A-004 40.00 240.0
Spice Premix C-001 3.93 23.6
Corn Starch A-005 4.33 26.0
100.00 600.0
Spice Premix C-100
Chili Powder A-006 31.75 7 lb. 8 oz.
Salt A-007 21.17 5 lb.
HVP A-008 19.05 4 lb. 8 oz.
Sugar A-009 12.70 3 lb.
Cumin, grd A-010 6.35 1 lb. 8 oz.
Onion powder A-011 5.85 1 lb. 6 oz.
Oregano, grd A-012 2.37 9 oz.
Garlic Powder A-013 0.76 3 oz.
100.00 23 lbs. 10 oz.
Batch Yield: 600 lbs.
Finished Product Yield: 595 lbs.
Ingredient Statement: Beef, Water, Tomato Paste, Corn Starch, Chili Powder, Salt, Hydrolyzed Vegetable Protein, Sugar,
Spice, Onion Powder, Garlic Powder.

Figure 4. A Food Product Formula Document.

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 GRAVY AND BEEF TIPS
CODE NUMBER: B-002
EFFECTIVE DATE: Today's Date
PRODUCT CODE: 1743
Critical Standards Standard Method
Meat Content minimum of 35% meat (fresh basis) Process Date
Salmonella negative in 100g #100
C. perfringens <10/g #101
Staphylococcus (coagulase positive) <10/g #102
Major Standards
Meat chunks size 3/8" to 5/8" chunks #200
Gravy color (#3, 4 or 5) Color Chart
Coliforms <10/g #103
E. coli <10/g #104
Minor Standards
Gravy Texture a smooth consistency & free of lumps #300
Product Flavor a mild meaty flavor & aroma #301
Standard Plate Count <25,000/g #105
Ingredient Statement: Water, beef, flour, tomato paste, corn starch, salt, HVP, spices, sugar.

Figure 5. Food Product Standards Format

of the processor. If the food product will support the measures of sensory properties can be costly due to
growth of a potential food poisoning organism, identify requirements for sophisticated equipment. Qualitative
the particular organism in the critical standards category testing using taste panels, is an alternative to quantitative
as opposed to a major or minor standard. measurements. Make a sensory evaluation for flavor,
odor and texture a part of a quality control program.
Some typical food poisoning organisms are Establish a reject level for each product standard
Salmonella, Clostridium botulinum, Staphylococcus along with acceptable methodology. Base minimum
aureus and Clostridium perfringens. Other reject levels upon regulatory requirements and practical
microbiological standards such as a standard plate count production experience. If a method of measurement is
(SPC), yeast or mold may be appropriate for classification nonexistent, then the standard is nonexistent.
as major or minor standards. For many products, The last element to product standards is a simple
especially those subjected to cooking or other thermal statement of ingredients as it will appear on the label.
processes, use Coliforms and E. coli analyses to show and Figure 5 shows a format for product standards.
control post process contamination of cooked foods.
Consider microorganisms that can cause food spoilage in
a particular food product when establishing product
Manufacturing Procedures
standards. Yeast and mold counts are essential to control For each product, document the method of
programs involving food items with low or restricted fabrication or processing procedures to ease duplication
moisture levels like flour or cereals. A simple standard from lot to lot, shift to shift and day to day. A simple
plate count is always a good general indicator for tracking way to approach this is a clear and concise "cookbook"
bacterial quality and should be considered at least a minor approach. Key steps in the process which can impact
criterion. upon yield, quality or production efficiency should be
The sensory properties of a food product are keys to highlighted. Examples of key process steps might be
the consumer acceptance. Flavor, texture, aroma and "mix for 3 minutes before adding spices" or "cook to a
appearance are criterion that should be defined to assure minimum internal temperature of 145 degrees F."
that the product meets design expectations. Qualitative Several key points to consider when identifying

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 Breaded Squash
Description: MANUFACTURING PROCEDURE
Date of Issue: Today’s Date
Authorized Products: Code #1234

Critical process control points are in italics.

1. Remove stems and trim back blossom ends about ½”. (#1) Operator shall trim away all damage caused by rot, insects, or
mechanical abuse; QC shall monitor.
2. Wash the squash, rinse and sanitize with water containing 125 parts per million (ppm) chlorine for five (5) minutes. (#2)
Operator shall adjust chlorine level; QC shall monitor.
3. Cross-cut squash into 3/16" thick slices.
4. Prepare batter according to Formula B-101. Load breading (Code 123) into breading machine.
5. Pass slices through the first batter/ breading operation. (#3) Batter viscosity shall be 80 ± 20 centipoise at 50°F. (Spindle
#5, speed 50 on Brookfield Viscometer, Model RV) Operator shall adjust as required; QC shall monitor.
6. Pass battered/breaded slices through second batter/breading operation. (#4) Batter viscosity shall be 80 ± 20 centipoise
at 50°F. (Spindle #5, speed 50 on Brookfield Viscometer, Model RV) Operator shall adjust as required; QC shall monitor.
Every four hours, discard batter in second batter reservoir.
7. Freeze breaded pieces using spiral freezer. (#5) Packout group leader shall insure all product is solidly frozen before
placing in boxes. QC shall monitor.
8. Prior to packing each lot, adjust tare on scale as determined by the average weight of 10 containers on this day. (#6) QC
shall record the average container weight of 10 containers every day. Pack frozen squash into four-pound boxes. #7) QC
shall check five boxes per day for net weight (4 lb.) And one box per day for piece count. (#8) Group leader shall record
all in-process data (chlorine level, batter viscosity, net weights) in process log.
9. Pack six boxes per shipping crate. Store in holding freezer at 0°F.

Figure 6. Manufacturing procedures for use by production and QC personnel

important processing operations are time, temperature, balance and rework are examples of measurements made
equipment required, order of addition for ingredients and during the manufacturing process. Base the kinds of in-
weight. process measurements used in each operation upon what
Manufacturing procedures also should include special is called Critical Control Points.
instructions to the line worker or quality control A critical control point is a step in the process or in
personnel. An example instruction could be, "cross product formulation where small differences, changes or
check" the net weight of five packages every hour. Figure mistakes can cause the finished product to be a health
6 shows a simple manufacturing procedure to be used by hazard, illegal or costly to the business. Critical control
production and quality control personnel. points are identifiable (Figure 6). Some critical control
Once prepared, make manufacturing procedures or points are defined by regulation when public health or
portions of the procedures available to production
employees. Use the document as an employee training
tool.
Even with the best procedures, employees will find a
"better" way to manufacture the product. Be open minded.
If the new way is better, use it; if not, explain why. The
key is for the employee to follow instructions.

In-Process Records
It is important to know what is happening with the
product and process during manufacturing. In-process
record keeping is a way of obtaining the information.
Both quality control and production personnel should
participate in maintaining a daily manufacturing log. The
specific product weight, temperature, size and shape, Figure 7. In-line check weight of packaged
ingredient usage, product yield, scrap or waste, material product.

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Figure 8. Critical Control Points from a Fresh Cucumber Process.

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 Figure 9. Employee records product change- Figure 10. Review and summarization of in-
over on in-process recording chart. Record process data is necessary to minimize the change
processing data during operation, not at the of a problem reoccurring.
end of the day.
Two basic packages are typically necessary for food
product identity are of concern. Cooking temperatures, products. The primary package encloses the food and has
pasteurization time and temperature or allowable levels of direct contact with the product. A film, jar, bottle, carton
ingredients are processing variables oftentimes defined by or box are some of the common primary packages. The
regulation. secondary package is used to assemble multiple
Critical control points may be self-imposed because packaged food items for shipment. The shipper or
of desired label statements on the part of the processor. secondary package provides protection, reduces handling
Net weight is one example while nutritional labeling is of each individual bottle or carton and is necessary for
another. The cost of a product can be increased by simple efficient movement of goods to the consumer. Some
employee mistakes. In this case, critical control points in packaged foods, particularly microwaveable products,
processing simply relate to those processing steps that have three package components: the pouch, the carton
influence yield or inferior product. and the shipping case.
In-process record keeping can be a manual or Poor packaging or labeling can create negative
automatic operation and in some cases both. Employee impressions relative to product quality. This is true for
participation in record keeping provides an opportunity both simple and complex packages or labels. Packaging
for pride in workmanship. In-process records also are a serves to protect the food product and allows shipment
means of making adjustments to the product or process of multiple units. Items for packaging consideration are:
and preventing substandard product. 1. A statement from the supplier that the packaging is
Turn in all in-process records to supervisory made of FDA and/or USDA approved materials. The
management for review at the end of a shift or working package composition should be listed on the
day. The supervisory review allows an opportunity to statement.
identify problem areas and to make changes to prevent 2. Dimensions of carton, jar, bottle or box.
reoccurrence. In some food processing operations, like a 3. Strength of the container and suitability for stacking,
poultry or red meat facility, these records are available to freezing or microwaving.
the on-site USDA inspector. 4. Strength of seals or fit of the lid. For heat sealed
packages, the temperature requirements for sealing
are critical.
Packaging and Labeling 5. Ability to restrict or allow air flow, moisture or
A quality control program should include packaging light. Permeability, thickness, flexibility and
and labeling. One of the first items that influence the temperature resistance are specific criteria in this
consumer is the appearance of the package and the label. category.

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 package is the main source for package specifications.
Local distributors can obtain the needed information
from the manufacturer.
Dimensions of the package, both inner and outer, are
defined to prevent problems such as under or over-fill,
shifting within the package, spillage or breakage of the
container. Lack of control can be costly for product loss,
giveaway or lost sales.
The strength of the container and the seals or the fit
of the lid are important considerations. Failure with
regard to these items can result in crushing, breakage or
spillage. Most important is the potential for physical or
microbiological contamination when a poor seal of
improperly fitting cap is a package defect.

Figure 11. Attractive food packaging protects

contents and helps assure customer satisfaction.
Good Manufacturing Practices
and Sanitation
6. Graphics (illustration, picture or visual designs). Federal regulations define specific procedures to
7. Label format and legal requirements. minimize the contamination of food products by people
in manufacturing, processing packaging and
Packaging must be selected or designed based upon warehousing facilities. The regulations are called Good
the particular food item. Fresh fruits and vegetables Manufacturing Procedures (GMPs). GMPs are an
require packaging that provides protection while allowing integral part of quality control. It is the respons-ibility of
air flow for proper cooling and respiration. Dairy products food business management and ownership to know,
require packaging to inhibit light penetration and practice, communicate and ensure that GMPs are carried
excessive oxygen because of the potential for flavor out by employees. An overview of GMPs is as follows:
defects due to oxidation, rancidity or the absorption of 1. Individuals with communicable diseases cannot
foreign flavor. A final example, the tea bag must provide work in areas where food contamination is possible.
permeability to moisture. This includes individuals with boils, sores or
Package graphics, by words or pictures, define the infected wounds.
contents and serve as point of purchase information. The 2. Food handlers must follow good personal hygiene
law requires product name, ingredient statement and practices.
manufacturing or distribution location to be on the a. Wear protective clothing.
package. Government regulations list many requirements b. Clean and sanitize hands and gloves.
for packaging and even extend to specifying the size or c. No jewelry.
type or printing. Pictures or other graphics are optional d. Use gloves (non-absorbent) when the job
and serve to inform the consumer. Overall graphics must requires hand covering.
represent the contents of the container so mislabeling or e. Use effective hair restraints and covering.
misbranding does not occur. Some typical package and f. Eat, drink or smoke only in designated areas.
label defects are smears, scuffs, color variations, broken 3. Train employees effectively in hygiene, sanitation
seals leaks, short fill and product infestation or spoil age. and pest control.
The defects can be found in both single unit packs and
multi-packs (shippers). Along with GMPs, a cleaning and sanitizing
It is to a food processor's advantage to develop program is essential. Cleaning and sanitizing should
packaging and label specifications along the same format address three basic areas:
as ingredient specifications. 1. Exterior facility and grounds.
Materials of construction are particularly important 2. Internal facility including floors, walls, ceilings and
where direct contact with the food is involved. Certain ventilation system.
chemicals or foreign materials from packaging materials 3. Equipment and all food contact areas.
can contaminate the food product. The packaging material
must meet FDA and/or USDA requirements. Use a
reputable packaging supplier. The manufacturer of the

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 note of any dirt, filth or residues and evidence of
previous spills.
6. Do not accept food, ingredient or packaging
shipments combined with chemicals or poisonous
substances.
7. If the shipment does not meet specifications, be
prepared to reject all or part of the load.
8. Minimize dock time. Move refrigerated or frozen
items directly into storage.
9. Date code all incoming shipments directly on the
container or pallet load for stock rotation.

Improper storage can adversely impact upon the

quality of materials, ingredients and finished product.
Storage in an orderly manner under proper conditions of
Figure 12. Employees wear gloves, hair covering and temperature and humidity is essential to quality. Certain
protective clothing to assure food safety. supplies or ingredients may require segregation.
Rotate the inventory. If not properly managed items
A cleaning and sanitizing program prevents the build may ruin in storage areas.
up of dirt and debris, maintains equipment in good repair, Shipping is the final step in which a food business
prevents growth and contamination from microorganisms can have direct control on product quality. Ship items on
and prevents the entry and harboring of insects and other a first-in-first-out basis and use the same guide-lines in
pests. The quality program should: outline specific shipping that you followed in receiving.
activities to be performed, any corrective measures,
schedules for cleaning and sanitizing, identify approved
cleaning compounds, sanitizers and baits and define a
Laboratory Analysis
standard. Keep and maintain proper records. The establishment of specifications and standards is
meaningless without laboratory analysis or an evaluation
program. Laboratory analysis is the phase in which a
Warehousing quality control program is implemented after product is
Warehousing involves three activities (receiving, storage produced. A sampling plan, along with an analysis
and shipping) that are included in a quality control frequency (time schedule defining how often analyses
program. The receiving operation is the foundation for are made), is absolutely necessary.
processing finished food products of a designated quality. Compile the methods of analysis used in the
Guidelines for incoming shipments are: laboratory in a special working notebook. Micro-
1. Be sure the storage space is clean and consistent with biological, chemical and physical analyses of food are
the first-in-first-out rotation principle. FIFO or first- available in the book, Official Methods of Analysis,
in-first-out rotation is the removal of inventory from published by the Association of Official Analytical
storage in a systematic way where earlier stock items Chemists. For some analyses, very simple methods are
are used first. This can be accomplished by date used in the laboratory. By example, for fruits or
coding the inventory according to the date of receipt. vegetables, color measurements and physical defects are
2. Before unloading, inspect the condition of the carrier. sometimes determined by comparing the product to a
Measure temperature, observe and note foul odors, chart. Other methods like a protein or fat analysis are
spills, and insects. For refrigerated and frozen more complicated and require specialized equipment.
products, temperature is critical. Microbiological methods performed on product
3. Observe the condition of the containers for damage whether it is poultry, red meat, dairy, vegetable or
which could be a source of contamination. seafood also requires special instruments and equip-
4. Collect random samples from the shipment and ment. Incubators and an autoclave are necessary in
analyze or evaluate the samples in relation to microbiological analyses. An incubator is used to control
specifications. temperature conditions and allow bacteria to grow so
5. After unloading, inspect the condition of the carriers groups of bacteria (colonies) can be counted. An
and notice the condition of the floors and walls. Take autoclave is like a steam cooker. This piece of equipment
is used to sterilize laboratory glassware and destroy

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bacteria, yeast or mold after an analysis. Destruction of An example of Class I product recall would be
the microorganisms is important so safe disposal is contamination with a toxic substance (chemical or
possible. microbiological). A Class II product recall is where
Perform all laboratory analyses in a room away from product is contaminated with food infection
the processing area. At times, a small food plant may not microorganisms, while a Class III example is where
have a separate area. Therefore, there are three ways to product does not meet a standard of identity.
obtain laboratory analysis results: Because of recall potential, a food business firm
1. In-house lab. must be prepared for the worst situation. A recall plan
2. Outside independent lab. should be developed and communicated to appropriate
3. Combination of in-house and independent lab. individuals within the firm before an emergency arises.
Appoint a qualified individual to conduct analyses, The plan should include:
report the results and manage the job of quality control. G An effective product coding system. Coding should
Have laboratory tests results recorded and compared to be simple, yet broad enough to minimize financial
the specifications or standards. Deviations from standards loss. Date of manufacture, date code plus shift code,
should be communicated so that additional action can be lot code or various combinations are possible.
taken if necessary. G A record keeping system to identify and associate
Many methods exist for the laboratory analysis of specific product, product code, carrier and
food. Examples of some methods are: destination.
G Standard plate count, a microbiological method used G A list of key personnel and their assigned
to count the numbers of bacteria contained in a responsibilities for a recall. Select key personnel
product. from each of the following areas: production, quality
G Yeast and mold count, a microbiological method used control, marketing, shipping/receiving and legal
to count the number of yeast and mold in food. counsel.
G A chemical method (pH) which determines if a food G A communication system within the firm and a
is acidic, neutral or basic. system into the distribution marketing shipping/
G Moisture, a chemical method to determine total water. receiving channels and legal counsel. A
communication system is critical to minimize rumor
G Protein, a chemical method to determine the protein. and the exaggeration or misstatement of the facts in
G Fat, a chemical method to determine total fat. and out of the business.
G Established procedures for evaluating and correcting
situations.
Recall Plan A good recall program is like an insurance policy.
Product recall is having to bring back product from The program will not prevent an adverse situation from
the distribution system. Every food business is susceptible occurring. It will, however, help the business and
to potential product recall. The public image of businesses personnel prepare for a possible recall.
can be destroyed during a recall if a well-organized plan Food quality is an expectation of consumers. To
is not implemented. meet this consumer need, every food business should
Why would a product be recalled? Products are develop and use an effective quality control program.
recovered from distribution as a result of voluntary action Failure to meet consumer demand can cause a decline in
by a business firm or involuntary action due to Food and product sales and profitability. A major product failure
Drug Administrative (FDA) action. The basic reasons for can totally destroy a business. Start or update quality
recall are best described by the FDA recall classifications: control practices now, and continue to build the program
CLASS 1 - As a result of a situation where there is for the future. In case there is doubt, ask two questions:
reasonable probability that the use or exposure to a 1. Are we doing things right?
defective product will cause a serious public health 2. Are we doing the right things?
hazard including death.
CLASS II - As a result of a situation where the use of
or exposure to a defective product may cause a
temporary adverse health hazard or where serious
adverse public health hazard (death) is remote.
CLASS III - As a result of a situation where use of or
exposure to a defective product will not cause a
public health hazard.

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 References
How to Prepare A Quality Assurance Plan, Food Warehousing. Department of Health and Human Services, Public
Health Service, U.S. Food and Drug Administration.
Gravani, Robert B. Food Science Facts for the Sanitarian, Dairy and Food Sanitation. April 1986.
Rust and Olson. Coping With Recalls, Meat and Poultry Vol. 33, No. 3, March 1987.

When you have a question ...

Call or visit your local office
of the University of Georgia’s
Cooperative Extension Service,
College of Agricultural and
Environmental Sciences.

You’ll find a friendly, well-trained staff ready

to help you with information, advice and free
publications covering agriculture and natural
resources, home economics, 4-H and youth
development, and resource development.

PUTTING KNOWLEDGE TO WORK

Trade and brand names are used only for information. The Cooperative Extension Service, University of Georgia
College of Agriculture does not guarantee nor warrant the standard of any product mentioned; neither does it imply
approval of any product to the exclusion of others which may also be suitable.

Prepared by Philip T. Tybor, William C. Hurst, A.E. Reynolds and G.A. Schuler of the Extension Food Science and
Technology Department.

Bulletin 997 August 1988, Reprinted February 1997

The University of Georgia and Ft. Valley State College, the U.S. Department of Agriculture and counties of the state cooperating.
The Cooperative Extension Service offers educational programs, assistance and materials to all people without regard to race, color,
national origin, age, sex or disability.

AN EQUAL OPPORTUNITY EMPLOYER

Issued in furtherance of Cooperative Extension work, Acts of May 8 and June 30, 1914, The University of Georgia College of
Agricultural and Environmental Sciences and the U.S. Department of Agriculture cooperating.
Gale A. Buchanan, Dean and Director